HEALICOIL REGENESORB 72203801Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885554031430), received between Sep 19, 2017 and Apr 9, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A HEALICOIL ANCHOR BROKE DURING SCREWING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A NEW BONE HOLE WAS DRILLED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Perforation

  MAUDE report 19076501 ↗
• MalfunctionMar 18, 2022Crack; Difficult to Insert; Crack; Difficult to Insert

  IT WAS REPORTED THAT DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE, THE HEALICOIL ANCHOR COULD NOT BE INSERTED INTO THE BONE HOLE, THE ANCHOR WAS CRACKED IN THE VERTICAL DIRECTION. THE BONE HOLE WAS MADE WITH A SHOULDER AWL STRAIGHT AND THE INSERTION SITE WAS CLEARED FROM ALL DEBRIS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13806496 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A HEALICOIL ANCHOR WAS USED ON A SHOULDER ROTATOR CUFF REPAIR. AFTER PROCEDURE IT WAS NOTICED THAT THE PATIENT GOT AN INFECTION. A REVISION SURGERY WAS REQUIRED FOR WASH OUT THE INFECTION. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13060687 ↗
• MalfunctionNov 4, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP, THE PACKAGING OF THE HEALICOIL WAS FOUND TO BE BADLY SEALED, THEREFORE, IT WAS OPENED IN THE BOX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752523 ↗
• MalfunctionSep 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE COMPONENTS BROKE AT THE UNION OF THE "5.5MM HEALICOIL REGENESORB SUTURE ANCHOR" AS SOON AS IT WAS INSERTED WITHOUT APPLYING ANY FORCE OR TENSION. THIS BREAKAGE TOOK PLACE OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454110 ↗
• InjurySep 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE COMPONENTS BROKE AT THE UNION OF THE "5.5MM HEALICOIL REGENESORB SUTURE ANCHOR" AS SOON AS IT WAS INSERTED WITHOUT APPLYING ANY FORCE OR TENSION. THIS BREAKAGE TOOK PLACE OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453864 ↗
• InjurySep 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE COMPONENTS BROKE AT THE UNION OF THE "5.5MM HEALICOIL REGENESORB SUTURE ANCHOR" AS SOON AS IT WAS INSERTED WITHOUT APPLYING ANY FORCE OR TENSION. THIS BREAKAGE TOOK PLACE OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453823 ↗
• MalfunctionSep 19, 2017Break

  IT WAS REPORTED THAT NOT ALL BROKEN PIECES COULD BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6875876 ↗
• MalfunctionSep 19, 2017Break

  IT WAS REPORTED THAT NOT ALL BROKEN PIECES COULD BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875565 ↗